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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: Caffeine
Trade Name: Cafcit
Date Designated: 09/20/1988
Orphan Designation: Treatment of apnea of prematurity.
Orphan Designation Status: Designated/Approved
O.P.R. Development, L.P.
1501 Wakarusa Drive
Lawrence, Kansas 66047
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: Caffeine
Trade Name: Cafcit
Marketing Approval Date: 09/21/1999
Approved Labeled Indication: Short term treatment of apnea of prematurity in infants between 28 and less than 33 weeks gestational age.
Exclusivity End Date: 09/21/2006 
Exclusivity Protected Indication* :  

*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.